Dexmethylphenidate hydrochloride

Product NDC
0115-1684
11-digit product format
001151684
Labeler code
0115
Product ID
0115-1684_02b0ea7c-8309-488d-92ab-118a4f7119fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA079108
Marketing category
ANDA
Marketing start
2014-11-11
Marketing end
0000-00-00
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1684-01EA - Each0115-16846f90c2f3-1288-44bc-8c95-03cc6785090712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1684DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]12Legacy NDC20231231_5312f2c3-bd73-4d29-b8d1-e989282be750.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1684-0100115168401100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1684-01) 2014-11-110000-00-00NoNoCurrent